Job description

Job Title: Global Product Quality Specialist

Location: Summit, NJ (50% Onsite)

Duration: 12 Months

This is a 50% Onsite Role

Job Description:

The Global Product Quality Specialist, will be responsible for managing (and owning as needed) documentation in electronic document management system and change controls associated with key deliverables to clinical and commercial documentation across multiple programs. Functional responsibilities include tracking of multiple work streams and collaborate across multiple functions (i.e. Site QA/QC, manufacturing, validation, IT, manufacturing science and technology, analytical development, etc.) to ensure all technical and compliance requirements are met per clinical and commercial development timelines. Support Change control, Deviation ,CAPA management, APQR(Annual Product Quality Review) and author and/or review GxP documents as required. Provide assistance to other Global Product Quality staff members as needed. Performs other QA duties as assigned.

Basic Qualifications:

• Minimum of 5-7 years of demonstrated success implementing complex business or technology initiatives.
• Minimum of 3 years working under GMP conditions. BA or BS degree.
• Experience managing document authoring reviewing and approving in electronic document system
• Strong written, verbal, and organizational skills, and ability to work in inter-disciplinary and cross-functional teams.
• Experience with eQRMS, infinity, electronic documentation systems (Veeva), and other quality systems is preferred.
• Experience with owning change controls is required.
• Scientific background with basic understanding of typical analytical methods and Quality Control
• Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products.
• Detail oriented with high degree of focus. Able to follow instructions and procedures, both written and verbal.
• Able to understand complex work practices.
• Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
• Able to perform with minimal supervision and contribute in a team environment.
• Basic knowledge and ability in using Microsoft Office Package.

Job Type: Contract

Salary: $65.00 - $69.00 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• Hybrid remote

COVID-19 considerations:
Candidate has to be fully vaccinated.

Work Location: Hybrid remote in Summit, NJ 07901

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